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target directory

avt03 biosimilar to denosumab clinical trial intelligence

Trials are included when the normalized target field matches this target directory. Full protocol, result, eligibility and IP analysis is available inside the premium workspace.

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target

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normalized field

NCT05876949
Source recordAI-normalized

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

AVT03 is a proposed biosimilar to Xgeva (denosumab), developed by Alvotech Swiss AG. The clinical trial aimed to compare the pharmacokinetic, safety, and immunogenicity profiles of AVT03 against the reference product in healthy male subjects aged 28 to 55. The study was completed with a total enrollment of 208 participants.

AI analysis

Indication: This is a Phase I Study Conducted in Healthy Volunteers

Modality: monoclonal antibody

Target: AVT03 (biosimilar to Denosumab)

Sponsor: Alvotech Swiss AG

Source URL: ClinicalTrials.gov

Source updated: May 15, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: AVT03 (biosimilar to Denosumab)

View original source fields

Condition raw: This is a Phase I Study Conducted in Healthy Volunteers

Condition normalized: This is a Phase I Study Conducted in Healthy Volunteers

Modality raw: This is a Phase I Study Conducted in Healthy Volunteers

Modality normalized: monoclonal antibody

Target raw: AVT03 (biosimilar to Denosumab)

Target normalized: AVT03 (biosimilar to Denosumab)

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